At CenPharma, we have a staff with over 40 years combined experience in all realms of quality, qualification, and validation. Our experience is as diverse as the clients we help with experts in microbiology, 503B operations, regulatory submission, regulatory inspection, and remediation project management.
Through our partnerships, we have extended our capabilities within engineering and facility design, analytical method development and testing, and ERP implementation. Our trained staff pairs with our partners to provide the compliance oversight to all of these activities and give you the one-stop shop you need to right size your project.
Diane is an accomplished Quality professional with over 20 years of extensive experience in the pharmaceutical industry. She holds both a Master's and Bachelor's degree in Chemical Engineering and has expertly transitioned between pivotal roles in Validation and Quality Assurance, contributing to both established pharmaceutical firms and innovative start-ups. Throughout her career, Diane has provided exceptional Quality oversight for products such as autologous immunotherapies, combination products, and biologics, and has developed and managed robust Validation programs tailored to those specific needs. Following her most recent role leading the Quality unit of a national organization, she founded CenPharma, LLC, where she offers invaluable expertise in Quality, Inspection Readiness, and Validation. Diane possesses in-depth knowledge of Quality Assurance, Quality Control, Compliance Remediation, Inspection Readiness, as well as Data Integrity, Computer System Validation, Cleaning and Process Validation. Her unique blend of experience enables her to effectively apply regulations and best practices across various sectors. Beyond her professional activities, Diane enjoys time spent with her family doing a myriad of activities. Both her boys are avid baseball players with both her husband and oldest son taking on the task of coaching her youngest. And, when not at the baseball field, she spends time perfecting new recipes, riding roller coasters with her eldest, and introducing her youngest to all things superhero and Harry Potter related.
Kairo is an experienced sales professional, a certified System Administrator, and a freelance Game Developer. He is an expert in Client Relationships, Business Efficiency, and Customer Satisfaction. He also has extensive knowledge of system networking, computer programming, and automation.
At CenPharma, we are dedicated to leveraging our expertise to help our clients meet their overall compliance objectives in support of their development and production goals. Our success is mirrored in the success of our clients providing meaningful medications to patients in need.